This clinical study is designed to evaluate the effectiveness of patient-specific occlusal splints created using MODJAW, a jaw-tracking device that records 3D mandibular movements. Occlusal splints are commonly used to treat bruxism (teeth grinding) and temporomandibular joint (TMJ) disorders, which can cause jaw pain, headaches, and worn teeth. Traditional splints are made using standard designs that do not consider each patient's unique jaw movements.

In this study, 40 participants with mild-to-moderate bruxism or TMJ dysfunction will be randomly assigned to two groups. One group will receive custom splints designed using MODJAW kinematic data, while the other group will receive standard occlusal splints. Participants will use their assigned splint for 8 weeks.

The study will measure:

Jaw movement patterns using MODJAW

TMJ pain levels

Patient comfort and satisfaction

The main goal is to determine whether MODJAW-based, patient-specific splints provide better jaw function, reduced pain, decreased teeth grinding, and higher patient satisfaction compared to standard splints.

Participants will be monitored throughout the study to ensure safety, comfort, and proper splint use. This study is expected to help dentists design more effective, personalized splints in the future and improve treatment outcomes for people with jaw disorders or bruxism.

Detailed Description:

Background and Rationale:

Bruxism and temporomandibular joint (TMJ) disorders are common conditions that can lead to jaw pain, headaches, tooth wear, and impaired quality of life. Occlusal splints are commonly prescribed to manage these conditions by stabilizing the jaw and distributing occlusal forces. Standard splints, however, are typically fabricated using uniform designs that do not account for the individual jaw movement patterns of each patient. Recent advances in digital dentistry, including the use of jaw-tracking devices such as MODJAW, allow clinicians to capture three-dimensional mandibular kinematics in real time. By using this information, occlusal splints can be designed to match the specific movement patterns of each patient, potentially improving comfort, jaw function, and clinical outcomes.

This study aims to evaluate whether patient-specific occlusal splints designed using MODJAW kinematic data provide superior clinical outcomes compared to standard occlusal splints.

Study Objectives:

To compare mandibular movement patterns between MODJAW-based patient-specific splints and standard occlusal splints.

To evaluate the effect of MODJAW-based splints on bruxism frequency and intensity.

To assess TMJ pain reduction in participants using MODJAW-based splints versus standard splints.

To determine patient satisfaction and comfort with patient-specific versus standard splints.

Study Design:

This is a prospective, randomized, controlled interventional study. Forty participants with mild-to-moderate bruxism or TMJ dysfunction will be randomly assigned to one of two groups:

MODJAW group (n=20): Participants will receive a patient-specific occlusal splint designed based on 3D mandibular kinematic data collected with MODJAW.

Standard splint group (n=20): Participants will receive a conventional occlusal splint fabricated using standard methods.

The study duration for each participant is 8 weeks, during which participants will wear their assigned splints according to instructions and attend follow-up assessments.

Inclusion Criteria:

Age 18-50 years

Diagnosed with mild-to-moderate bruxism or TMJ dysfunction

Willingness and ability to comply with splint use and study visits

Signed informed consent

Exclusion Criteria:

Severe dental loss or existing prosthetic devices interfering with splint placement

Systemic medical conditions affecting jaw function

History of TMJ trauma or surgery

Pregnancy or breastfeeding

Allergy to splint materials

Study Procedures:

Screening and Baseline Assessment:

Clinical examination of dentition and TMJ

Recording baseline jaw movements using MODJAW (for both groups)

Baseline assessment of bruxism frequency, TMJ pain (VAS score), and patient-reported comfort

Splint Fabrication:

MODJAW group: CAD/CAM splints designed using mandibular movement data captured by MODJAW

Standard group: Conventional splints fabricated according to standard occlusal design

Splint Use:

Participants instructed to wear splints nightly (or as directed) for 8 weeks

Weekly check-ins to monitor compliance and comfort

Follow-Up Assessments (Week 4 and Week 8):

Repeat MODJAW recordings to evaluate changes in mandibular movement

Assess TMJ pain, bruxism frequency and intensity

Collect patient satisfaction and comfort scores via 5-point Likert scale

Record any adverse events

Outcome Measures:

Primary Outcome: Changes in mandibular movement patterns as measured by MODJAW

Secondary Outcomes:

Reduction in TMJ pain (VAS score)

Patient-reported satisfaction and comfort

Data Analysis:

Within-group comparisons: Paired t-tests or Wilcoxon signed-rank tests

Between-group comparisons: Mann-Whitney U test

Categorical outcomes: Chi-square or Fisher's exact test

Statistical significance set at p < 0.05

Safety Considerations:

Participants monitored for adverse events related to splint use, including discomfort, tissue irritation, or allergic reactions

Participants may withdraw at any time

All data handled according to confidentiality and privacy guidelines

Significance:

This study will provide evidence on the effectiveness of patient-specific, MODJAW-guided occlusal splints in improving jaw function, reducing bruxism, and increasing patient satisfaction. The results may support the adoption of kinematic data in routine occlusal splint design and contribute to personalized dentistry approaches.

Inclusion Criteria:

• Age 18-50 years
• Diagnosed with mild-to-moderate bruxism or temporomandibular joint (TMJ) dysfunction
• Willingness and ability to comply with splint use and study visits
• Signed informed consent

Exclusion Criteria:

• Severe dental loss or existing prosthetic devices interfering with splint placement
• Systemic medical conditions affecting jaw function
• History of TMJ trauma or surgery
• Pregnancy or breastfeeding
• Allergy to splint materials

Individual participant data (IPD) from this study will not be shared. The study involves patient-specific dental records and intraoral imaging that are considered sensitive and personally identifiable. To protect participant privacy and comply with ethical standards, raw data containing personal identifiers will remain confidential and will not be made publicly available. Aggregate or de-identified summary data may be shared upon reasonable request with qualified researchers following approval from the study team and institutional review board.

Not applicable; this is an open-label study.